Actively Recruiting
Improving Colorectal Cancer Early Screening in Portugal: Identification of Gut Microbiome Biomarkers in Stool (GUTBIOME-PT)
Led by Gulbenkian Institute for Molecular Medicine · Updated on 2026-05-14
30000
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
G
Gulbenkian Institute for Molecular Medicine
Lead Sponsor
H
Hospital CUF Descobertas, Lisbon, Portugal
Collaborating Sponsor
AI-Summary
What this Trial Is About
Colorectal cancer (CRC) is a major public health problem, responsible for 2 million new cases and almost 1 million deaths annually worldwide. In Portugal, as of 2022, CRC is the most common cancer, with 10,575 new cases reported, and the second leading cause of cancer-related mortality, accounting for 4,809 deaths (approximately 14% of all cancer-related deaths). In recent years, there has been an alarming increase in the incidence and mortality of CRC in people \<50 years of age. Early detection is crucial, as survival rates decline sharply from 90% when detected early to just 10% in advanced stages. Non-invasive diagnostic tests, such as the Faecal Immunochemical Test (FIT), have a low sensitivity for early-stage lesions and a high rate of false positives. Therefore, there is an urgent need to improve non-invasive diagnostic methods for the early detection of CRC, as effective screening can prevent it by detecting and removing premalignant lesions. Recent studies suggest that an altered gut microbiota may confer susceptibility to certain types of cancer. Interestingly, the gut microbiota of patients with adenomas or CRC differs from that of healthy individuals. This study aims to identify gut microbiome biomarkers in faecal samples associated with CRC and/or high-risk adenomas to improve early detection.
CONDITIONS
Official Title
Improving Colorectal Cancer Early Screening in Portugal: Identification of Gut Microbiome Biomarkers in Stool (GUTBIOME-PT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide written informed consent and comply with study procedures
- Reside in the Lisbon Metropolitan Area, Portugal
- Age from 40 to 74 years
You will not qualify if you...
- Age under 40 years or 75 years and older
- Unable to provide informed consent
- Refusal to provide stool samples
- Active oncological disease
- Personal history of colorectal cancer
- Personal history of colon adenomas removed in the last 24 months
- First-degree family history of colorectal cancer
- Previous diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease or indeterminate colitis), inflammatory bowel syndrome, persistent and infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhoea of unknown cause or recurrent infection by Clostridioides difficile
- Severe cardiovascular or heart diseases with medical diagnosis
- Severe renal failure requiring hemodialysis
- Severe lung disease
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gulbenkian Institute for Molecular Medicine
Lisbon, Lisbon District, Portugal, 1649-028
Actively Recruiting
Research Team
A
Ana S Almeida, PhD
CONTACT
M
Madalena Reis
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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